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Tumor Marker CA15-3 Carbohydrate Antigen 153 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box

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Tumor Marker CA15-3 Carbohydrate Antigen 153 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box

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Brand Name : Zecen

Model Number : CLIA, POClia

Certification : ISO 13485, CE, FSC,

Place of Origin : China, Taizhou

MOQ : 100T (1 BOX),48T (2 BOX)

Price : Negotiable

Payment Terms : L/C, D/A, D/P, T/T, Western Union, MoneyGram

Supply Ability : 10000 T/Month/Project

Delivery Time : 10 Days

Packaging Details : In: Bottle and Strip; Out: Box

Packaging : reagents bottles, reagents strip

Storage : 2~8℃

CV : <=3%

Classification : Tumor Marker

Test throughput : 120+ tests/hour

Validity period : 18 months

Calibration : 6 points

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Tumor Marker CA15-3 Carbohydrate Antigen 153 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box

INTENDED USE

The kit has been designed for the quantitative determination of Cancer antigen 15-3 (CA15-3) in human serum.

The method can be used for samples over the range of 1.0～600.0 U/mL .

The test has to be performed on the CIA fully auto analyzer (Including CIA 600, CIA 1200, CIA 1800, CIA2800).

KIT COMPONENTS

Material Supplies

Reagent Integral for 50 determinations

Magnetic beads: BSA buffer with magnetic

beads complex with anti-FITC

 1×1.5mL
Calibrator A-F: BSA buffer with different levels of CA15-3 antigen 6×0.25mL
CA15-3 Anti: BSA buffer with CA15-3 antibody labeled by FITC and CA15-3 Antibody labeled by AP. 1×3.0mL
Sample Dilution 2:This dilution is composed of Nacl, BSA and Tris buffer with Proclin-300. 1×12.5mL
All reagents are provided ready-to-use.

Reagent Integral for 100 determinations

Magnetic beads: BSA buffer with magnetic

beads complex with anti-FITC

 1×3.0mL
Calibrator A-F: BSA buffer with different levels of CA15-3 antigen 6×0.5mL
CA15-3 Anti: BSA buffer with CA15-3 antibody labeled by FITC and CA15-3 Antibody labeled by AP. 1×6.0mL
Sample Dilution 2:This dilution is composed of Nacl, BSA and Tris buffer with Proclin-300. 1×25mL
All reagents are provided ready-to-use.
Reagent Vials in kit box 50T 100T
Control 1: BSA buffer with low level of CA15-3 Antigen 1×0.25 mL 1×0.5 mL
Control 2: BSA buffer with high level of CA15-3 Antigen 1×0.25 mL 1×0.5 mL
target value refer to Quality Control sheet

Accessories Required But Not Provided

Substrate REF: SR2001
System washing solution REF: WR2001
Probe washing solution REF: WR2002

product composition Two points: LH
Six points: ABCDEF
Testing method 1. Treat the calibrator as the sample to be tested, and place it in the sample loading area of the instrument after mixing. Note that when mixing Avoid air bubbles.
2. During the detection, the system detects the luminescence value (RLU value) of each calibration point, and calculates the luminescence value according to the nominal concentration and luminescence value.
The calibration curve is automatically fitted by the instrument. In order to ensure the reliability of the calibration curve, the determination of the calibrator should be
Make a double.
3. The generated calibration curve can be used for 28 days, but it should be re-calibrated after the following conditions:
① Change of batch number of supporting testing reagents;
Change of batch number of luminescent substrate
②The measured value of the quality control product is not within the scope of quality control or the test results are inconsistent with the clinical situation;
③System for major repairs or maintenance.
Interpretation of test results 1. For reasons such as methodology or antibody specificity, the same sample was tested using reagents from different manufacturers.
Testing with different reagents may give different test results, therefore, the results obtained by testing with different reagents should not be directly
They are compared with each other in order to avoid false medical interpretations.
2. The quality control product can be used as a reference for the reliability of the current experimental results, and its measured value should be within the
within the range allowed by the quality control sheet. Test results should be based on reference value ranges and other clinical factors and results
Comprehensive judgment, when the test result is close to the upper limit or lower limit of the reference value range, it can be considered
samples for confirmation testing.
Storage and expiration date Stored at 2-8°C, the product is valid for 12 months. Reagents should be used within 1 month after opening, and stored at 2-8°C away from direct sunlight.

Tumor Marker CA15-3 Carbohydrate Antigen 153 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box


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